Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-10.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Sep 2019 – 10 Sep 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jun 2013 – 27 Jun 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Aug 2010 | Not recorded | 483 | View 483 → |
| 23 Mar 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Sep 2019
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Sara M Onyango
10 Sep 2019
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Sara M Onyango
10 Sep 2019
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Sara M Onyango
Investigators
FDA investigators tied to this site in the record.
Sara M Onyango1 insp.
Tamara S Rosbury1 insp.
Lauren B Brown1 insp.
Jonathan B Lewis1 insp.
Darin S Wiegers1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ONC Solutions Incorporated's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat